The diagnosis of a given disease requires standard agreed-upon observations usually made by the attending physician of the sick patient. For some diseases, a single test is available which gives nearly definitive results sufficient for a correct diagnosis, for example, the glucose tolerance test for diabetes. However, most diseases require a number of sophisticated tests to arrive at a probable diagnosis. At the present time, therapeutic interventions are frequently initiated at late stages of disease, often resulting in only modest improvements in the quality and length of the affected patients life. Disease prevention is easier and more effective than disease therapy. Earlier diagnosis decreases disease-associated morbidities, increases the quality and length of life of the patient and decreases overall costs of health care. Thus, it is a goal of biomedical researchers to develop diagnostic tests which can correctly diagnose disease at the early stages.
Early diagnosis of congestive heart failure (CHF) is particularly beneficial since the cardiac re-structuring which occurs with progressive disease may be slowed or prevented with early therapeutic intervention. However, early diagnosis has proven elusive since symptoms generally do not appear until the heart has already suffered structural changes.
CHF is a serious condition with a high mortality rate affecting approximately five million Americans (see U.S. Pat. No. 6,572,895 for a discussion of CHF). It is currently believed that CHF is not a distinct disease process in itself, but rather represents the effect of multiple abnormalities which interact together to ultimately produce the progressive loss of the ability of the heart to function as a circulatory pump. Major pathophysiologic abnormalities which occur in CHF are activation of the hypothalmic-pituitary-adrenal axis, systemic endothelial dysfunction and myocardial re-structuring. The progression of CHF can be initiated by an event such as myocardial infarction wherein the heart muscle is damaged or it can result from hypertension and/or cardiac malformations. Recently, it has been discovered that patients with certain conditions such as insulin resistance and Type II diabetes have a particularly high risk for heart failure and poor prognosis once they develop CHF (Solang et al. European Heart Journal 20:789-795 1999).
Disease processes, such as those which occur in diabetes and CHF, often result in cellular and/or tissue damage followed by the release of cellular and/or tissue specific biopolymer markers into the bodily fluids of an individual. These biopolymer markers are harbingers of disease and/or disease progression. Association of such biopolymer markers with abnormal and/or disease states provides new diagnostic avenues which may allow identification of patients in the early stages of disease or patients at risk for developing disease. Identification of biopolymer markers diagnostic for CHF is particularly advantageous considering the progressive pathophysiology involved in CHF. What is lacking in the art is an efficient, easy to perform diagnostic method capable of identifying an individual suffering from CHF.